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EP2560691B2 - Procédé pour préparer une composition d'immunoglobuline - Google Patents
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EP2560691B2 - Procédé pour préparer une composition d'immunoglobuline - Google Patents

Procédé pour préparer une composition d'immunoglobuline

Info

Publication number
EP2560691B2
EP2560691B2 EP11715928.5A EP11715928A EP2560691B2 EP 2560691 B2 EP2560691 B2 EP 2560691B2 EP 11715928 A EP11715928 A EP 11715928A EP 2560691 B2 EP2560691 B2 EP 2560691B2
Authority
EP
European Patent Office
Prior art keywords
igm
solution
preparation
uvc
octanoic acid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP11715928.5A
Other languages
German (de)
English (en)
Other versions
EP2560691A2 (fr
EP2560691B1 (fr
Inventor
Wolfgang Möller
Dieter Rudnick
Oliver Maneg
Michael Rodemer
Herbert Dichtelmueller
Eckhard Flechsig
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biotest AG
Original Assignee
Biotest AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42270688&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP2560691(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Biotest AG filed Critical Biotest AG
Priority to PL11715928T priority Critical patent/PL2560691T3/pl
Publication of EP2560691A2 publication Critical patent/EP2560691A2/fr
Application granted granted Critical
Publication of EP2560691B1 publication Critical patent/EP2560691B1/fr
Publication of EP2560691B2 publication Critical patent/EP2560691B2/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/06—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations
    • A61K49/08—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by the carrier
    • A61K49/10—Organic compounds
    • A61K49/14—Peptides, e.g. proteins
    • A61K49/16—Antibodies; Immunoglobulins; Fragments thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/12—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1203—Gram-negative bacteria
    • C07K16/121—Helicobacter (G); Campylobacter (G)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/12—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1203—Gram-negative bacteria
    • C07K16/1228—Enterobacterales (O), e.g. Citrobacter (G), Serratia (G), Proteus (G), Providencia (G), Morganella (G) or Yersinia (G)
    • C07K16/1232—Escherichia (G)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/12—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1203—Gram-negative bacteria
    • C07K16/125—Gram-negative bacteria from Chlamydiales (O)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/12—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1267—Gram-positive bacteria
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/12—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1267—Gram-positive bacteria
    • C07K16/1275—Streptococcus (G)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/14—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from fungi, algea or lichens
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/30—Extraction; Separation; Purification by precipitation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Inorganic Chemistry (AREA)
  • Radiology & Medical Imaging (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (9)

  1. Procédé pour la préparation d'une composition d'immunoglobulines contenant des IgM à partir d'une fraction de plasma comprenant des immunoglobulines, le procédé comprenant:
    (a) la fourniture d'une fraction de plasma sous forme d'une solution contenant les immunoglobulines;
    (b) le mélange d'un acide octanoïque avec la solution et le traitement de la solution mixte avec un agitateur vibratoire pour provoquer la précipitation des protéines contaminantes; et
    (c) la séparation des protéines précipitées de la solution pour obtenir la composition d'immunoglobulines contenant des IgM.
  2. Procédé suivant la revendication 1, dans lequel, dans l'étape (b):
    (i) la concentration de l'acide octanoïque est d'au moins 0,075 kg/kg de fraction de plasma; et/ou
    (ii) le pH de la solution mixte est compris entre 4,5 et 5,5; et/ou
    (iii) la température de la solution mixte va de 10°C à 35°C; et/ou
    (iv) l'acide octanoïque est mis en incubation avec la solution contenant les immunoglobulines pendant au moins 30 minutes.
  3. Procédé suivant la revendication 1 ou la revendication 2, dans lequel:
    (i) les immunoglobulines de la fraction de plasma comprennent au moins 5 % de IgM; et/ou
    (ii) la fraction de plasma est un précipité de fraction I/III de Cohn ou de fraction de Kistler/Nitschmann B ou B+I; et/ou
    (iii) l'étape (c) comprend une ultrafiltration et la composition d'immunoglobulines comprend une solution filtrée.
  4. Procédé suivant l'une quelconque des revendications précédentes, comprenant en outre une étape d'incubation de la composition d'immunoglobulines contenant des IgM de l'étape (c) à un pH entre 3,5 et 4, pour former une solution incubée, et de préférence dans lequel l'étape d'incubation de la composition d'immunoglobulines contenant des IgM de l'étape (c) est mise en oeuvre à une température entre 32 et 42°C.
  5. Procédé suivant la revendication 4, comprenant en outre les étapes consistant à soumettre la solution incubée à une adsorption sur DEAE-Sephadex et à séparer le DEAE-Sephadex de la solution par filtration profonde.
  6. Procédé suivant la revendication 5, comprenant en outre l'étape consistant à soumettre le filtrat de la filtration profonde à une nanofiltration, et de préférence dans lequel la nanofiltration est effectuée avec un filtre ayant un diamètre nominal des pores de 35 à 75 nm et plus avantageusement un diamètre nominal des pores de 40 à 50 nm.
  7. Procédé suivant l'une quelconque des revendications 4 à 6, comprend en outre une étape de traitement de la solution incubée de la revendication 4 ou du filtrat de la revendication 5 ou de la revendication 6 à une irradiation UVC pour former une solution ayant subi une irradiation UVC, et de préférence dans lequel la solution incubée ou le filtrat est traité par une irradiation UVC à 200 à 500 J/m2, et plus avantageusement à 200 à 300 J/m2.
  8. Procédé suivant la revendication 7, comprenant en outre l'étape de filtration de la solution ayant subi une irradiation UVC dans des conditions stériles pour produire une préparation d'anticorps apte à l'administration intraveineuse, et comprenant en outre de préférence la formulation de la préparation d'anticorps dans un tampon contenant de la glycine à un pH entre 4 et 5,5.
  9. Procédé suivant la revendication 7 ou la revendication 8:
    (i) le procédé comprenant en outre une étape de remplissage d'un récipient avec la solution ayant subi une irradiation UVC de la revendication 7 ou la préparation d'anticorps de la revendication 8 dans des conditions stériles; et/ou
    (ii) dans lequel la solution ayant subi une irradiation UVC de la revendication 7 ou la préparation d'anticorps de la revendication 8 a une activité protéolytique inférieure à 8 U/l; et/ou
    (iii) le procédé provoquant une élimination supérieure à 3 log10 des virus sans enveloppe.
EP11715928.5A 2010-04-22 2011-04-21 Procédé pour préparer une composition d'immunoglobuline Active EP2560691B2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL11715928T PL2560691T3 (pl) 2010-04-22 2011-04-21 Sposób wytwarzania kompozycji immunolobulinowej

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1006753.6A GB201006753D0 (en) 2010-04-22 2010-04-22 Process for preparing an immunolobulin composition
PCT/EP2011/056486 WO2011131786A2 (fr) 2010-04-22 2011-04-21 Procédé pour préparer une composition d'immunoglobuline

Publications (3)

Publication Number Publication Date
EP2560691A2 EP2560691A2 (fr) 2013-02-27
EP2560691B1 EP2560691B1 (fr) 2015-11-04
EP2560691B2 true EP2560691B2 (fr) 2026-04-29

Family

ID=42270688

Family Applications (2)

Application Number Title Priority Date Filing Date
EP11715567.1A Active EP2560682B2 (fr) 2010-04-22 2011-04-21 Préparation d'anticorps
EP11715928.5A Active EP2560691B2 (fr) 2010-04-22 2011-04-21 Procédé pour préparer une composition d'immunoglobuline

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP11715567.1A Active EP2560682B2 (fr) 2010-04-22 2011-04-21 Préparation d'anticorps

Country Status (18)

Country Link
US (6) US8900806B2 (fr)
EP (2) EP2560682B2 (fr)
JP (4) JP6118248B2 (fr)
KR (2) KR101860459B1 (fr)
CN (3) CN102939107B (fr)
AU (2) AU2011244240B2 (fr)
CA (2) CA2796263C (fr)
CO (2) CO6640238A2 (fr)
ES (2) ES2553385T3 (fr)
GB (1) GB201006753D0 (fr)
HU (2) HUE028581T2 (fr)
IL (2) IL222374A (fr)
MX (2) MX338195B (fr)
PL (2) PL2560682T5 (fr)
RU (4) RU2617532C2 (fr)
SG (2) SG184843A1 (fr)
WO (2) WO2011131787A2 (fr)
ZA (2) ZA201208541B (fr)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201006753D0 (en) 2010-04-22 2010-06-09 Biotest Ag Process for preparing an immunolobulin composition
FR2959821B1 (fr) * 2010-05-05 2012-07-06 Lab Francais Du Fractionnement Procede de mesure de l'activation du complement par des igg
FR2974301B1 (fr) 2011-04-20 2013-08-23 Lab Francais Du Fractionnement Procede de preparation d'un produit plasmatique deplete en un ou plusieurs facteurs thrombogenes
FR2977893B1 (fr) * 2011-07-11 2015-02-20 Lab Francais Du Fractionnement Procede de preparation d'un concentre d'immunoglobulines polyvalentes
EP2636684A1 (fr) 2012-03-09 2013-09-11 CSL Behring AG Prévention des infections
EP2636681A1 (fr) 2012-03-09 2013-09-11 CSL Behring AG Procédé d' enrichissement d'IgA
BR112014022240A2 (pt) 2012-03-09 2017-08-01 Csl Behring Ag composições compreendendo imunoglobulinas semelhantes à secretoras
KR20150115639A (ko) * 2014-04-04 2015-10-14 전숙영 치료용 면역글로불린 제제 제조에 사용되는 산성 완충액, 이를 이용한 치료용 면역글로불린 제제 제조방법 및 이 제조방법으로 제조된 치료용 면역글로불린 제제
WO2016011054A2 (fr) * 2014-07-15 2016-01-21 The Regents Of The University Of California Nouveau traitement de la polykystose des reins
DK3334747T5 (da) 2015-08-13 2024-10-07 Amgen Inc Ladet dybdefiltrering af antigenbindende proteiner
AU2017233923B2 (en) * 2016-03-14 2023-10-12 Biotest Ag Treatment of severe Community Acquired Pneumonia
EP3275897A1 (fr) 2016-07-27 2018-01-31 Biotest AG Procédé de préparation de compositions d'immunoglobuline
RU2660584C1 (ru) * 2017-06-06 2018-07-06 Федеральное государственное бюджетное учреждение науки "Кировский научно-исследовательский институт гематологии и переливания крови Федерального медико-биологического агентства" Способ определения FC-функции препаратов иммуноглобулина человека
MX2020004921A (es) 2017-11-29 2020-08-27 Hoffmann La Roche Ensayo de anticuerpo antifarmaco con supresion de interferencia del objetivo.
EP3747903A1 (fr) 2019-06-07 2020-12-09 Biotest AG Procédé et kit d'essai de puissance de compositions d'immunoglobuline
KR20220166819A (ko) * 2020-04-10 2022-12-19 바누디스 게엠베하 예방 및 치료에서의 천연 항체
TW202200205A (zh) * 2020-06-03 2022-01-01 愛爾蘭商格里佛全球營運有限公司 超免疫ｉｇｇ及／或ｉｇｍ組合物及其製備方法及從供體中獲得超免疫人血漿的方法
UY39318A (es) * 2020-07-10 2022-02-25 Grifols Worldwide Operations Ltd Procedimiento para obtener una composicion que comprende inmunoglobulina m derivada de plasma humano
CN111944043B (zh) * 2020-09-01 2023-05-09 华兰生物工程重庆有限公司 一种从血浆废弃物中提取IgM的方法
CA3195385A1 (fr) 2020-11-19 2022-05-27 Biotest Ag Methode et kit d'essai d'efficacite immunomodulatrice de compositions d'immunoglobulines, par exemple pour le traitement de la covid-19
CA3223881A1 (fr) 2021-07-29 2023-02-02 Roopsee ANAND Procede de purification d'immunoglobuline g et ses utilisations
EP4689667A1 (fr) 2023-03-29 2026-02-11 CSL Behring AG Procédés d'identification d'immunoglobuline associée à des réactions indésirables
CN121712573A (zh) 2023-07-04 2026-03-20 瑞士杰特贝林生物制品有限公司 纯化方法
WO2025229607A1 (fr) 2024-05-03 2025-11-06 Csl Behring Ag Systèmes et procédés de séparation solide-liquide
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